One-hundred-sixteen patients suffering from vascular headache (migraine or combined migraine and tension) were, after 4 weeks of pretreatment baseline headache monitoring, randomly assigned to one of four conditions: (a) thermal biofeedback with adjunctive relaxation training (TBF); (b) TBF plus cognitive therapy; (c) pseudomediation as an ostensible attention-placebo control; or (d) headache monitoring. The first three groups received 16 individual sessions over 8 weeks, while the fourth group continued to monitor headaches. All groups then monitored headaches for a 4-week posttreatment baseline. Analyses revealed that all treated groups improved significantly more than the headache monitoring group with no significant differences among the three treated groups. On a measure of clinically significant improvement, the two TBF groups had slightly higher (51%) degree of improvement than the meditation group (37.5%). It is argued that the attention-placebo control became an active relaxation condition.
"From a comprehensive meta-analysis of three arm trials , only five studied headache exclusively [45–49]; unfortunately, none of these studies considered the actual IHS classification. Only one three arm trial concerned oral medication, given 2 weeks, and did not evidence for a difference in headache score between the placebo an no-treatment . "
[Show abstract][Hide abstract] ABSTRACT: We present a theory according which a headache treatment acts through a specific biological effect (when it exists), a placebo effect linked to both expectancy and repetition of its administration (conditioning), and a non-specific psychological effect. The respective part of these components varies with the treatments and the clinical situations. During antiquity, suggestions and beliefs were the mainstays of headache treatment. The word placebo appeared at the beginning of the eighteenth century. Controversies about its effect came from an excessive interpretation due to methodological bias, inadequate consideration of the variation of the measure (regression to the mean) and of the natural course of the disease. Several powerful studies on placebo effect showed that the nature of the treatment, the associated announce, the patients' expectancy, and the repetition of the procedures are of paramount importance. The placebo expectancy is associated with an activation of pre-frontal, anterior cingular, accumbens, and periacqueducal grey opioidergic neurons possibly triggered by the dopaminergic meso-limbic system. In randomized control trials, several arms design could theoretically give information concerning the respective part of the different component of the outcome and control the natural course of the disease. However, for migraine and tension type headache attacks treatment, no three arm (verum, placebo, and natural course) trial is available in the literature. Indirect evidence of a placebo effect in migraine attack treatment, comes from the high amplitude of the improvement observed in the placebo arms (28% of the patients). This figure is lower (6%) when using the harder criterium of pain free at 2 h. But these data disregard the effect of the natural course. For prophylactic treatment with oral medication, the trials performed in the last decades report an improvement in 21% of the patients in the placebo arms. However, in these studies the duration of administration was limited, the control of attacks uncertain as well as the evolution of the co-morbid psycho-pathology. Considering the reviews and meta-analysis of complex prophylactic procedures, it must be concluded that their effect is mostly linked to a placebo and non-specific psychological effects. Acupuncture may have a slight specific effect on tension type headache, but not on migraine. Manual therapy studies do not exhibit difference between manipulation, mobilization, and controls; touch has no proven specific effect. A comprehensive efficacy review of biofeedback studies concludes to a small specific effect on tension type headache but not on migraine. A review of behavioral treatment conclude to an interesting mean improvement but did not demonstrated a specific effect with the exception of a four arm study including a pseudo meditation control group. Expectation-linked placebo, conditioning, and non-specific psychological effects vary according clinical situations and psychological context; likely low in RCT, high after anempathic medical contact, and at its maximum with a desired charismatic healer. The announcements of doctors strongly influence the beliefs of patients, and in consequence their pain and anxiety sensibilities; this modulates the amplitude of the placebo and the non-specific psychological effects and is therefore a major determinant of the therapeutic success. Furthermore, any repetitive contact, even through a placebo, may interfere positively with the psychopathological co-morbidity. One has to keep in mind that the non-specific psychological interactions play a major role in the improvement of the majority of the headache sufferers.
The Journal of Headache and Pain 02/2012; 13(3):191-8. DOI:10.1007/s10194-012-0422-0 · 2.80 Impact Factor
"Dr. Seth Alalgia is planning a study as to whether yet another form of biofeedback therapy can reduce, at least in the short term, the frequency and severity of vascular headaches (cf. Blanchard et al., 1990). Specifically, he plans to conduct a double-blind, randomized trial in which patients will receive either an enhanced thermal (ET) biofeedback therapy or a sham placebo (SP) that simply gives non-contingent feedback to the patient. "
[Show abstract][Hide abstract] ABSTRACT: 8.1 INTRODUCTION Determining adequate and efficient sample sizes is often critical in designing worthy studies. Yet too many studies have sample sizes that are too small to ensure enough statistical power to confirm meaningful effects. Freiman, Chalmers, Smith, and Kuebler (1979) concluded this about clinical trials in medicine. Sedlmeier and Gigerenzer (1989) reached a similar judgment about studies in psychology. The message in both articles is cogent to all fields that rely on statistical inference. Perhaps such articles are having positive effects, for we see signs that researchers are now paying more attention to power. For example, reviewers of research proposals now often require that sound power analyses be done before they will recommend funding or access to facilities and subject populations. Going through the process of determining and justifying the sample size also has an important ancillary effect: it catalyzes the synergism between science and statistics at the study's conception. The statistician who performs a thorough power analysis is more likely to scrutinize the proposed design, assess issues regarding data management, and develop a sound plan for the data analysis. Such involvement can improve the proposal in a number of ways, thus increasing its chance for approval, funding, scientific success, and publication. In this chapter, we present a strategy for performing power analyses that is applicable to the broad range of methods subsumed by the classical normal-theory univariate or multivariate general linear models. First, we introduce the requisite concepts of statistical power using concepts from the familiar t-test to compare two independent group means. Second, we proceed to the comparison of two correlated means (matched-pairs problem) and on to the one-way analysis of variance (ANOVA) with contrasts for a completely randomized design. Third, we develop power analysis for the univariate general linear model, thus providing a broad range of applications. We illustrate this with an analysis of covariance (ANCOVA) problem that has unequal distributions of the covariate's values 1 Supported in part by grants from the US National Institutes of Health (GCRC: RR00082) and the University of Florida Division of Sponsored Research, which funded Zhanying Bai and Yonghwan Um in their wriitng of one portion of the OneWyPow.sas freeware module. Dan Bowling helped in many ways.
[Show abstract][Hide abstract] ABSTRACT: Biofeedback is an established non-pharmacologic technique commonly used in the treatment of migraine and tension type headaches. Multiple published studies have suggested that biofeedback is effective in reducing the frequency and severity of headaches, often allowing patients to decrease their dependence on medication. Studies have also suggested that biofeedback may effect a decrease in medical utilization.
Assess the efficacy of biofeedback in reducing the frequency and severity of migraine and tension type headaches.
Randomized, prospective, single blind, single center controlled trial.
Sixty-four patients with migraine with or without aura and/or tension type headaches, by ICHD-1 criteria, age 18 to 55, who had suffered from headaches for more than one year, were entered into the study. Patients were randomly assigned to receive biofeedback in addition to the basic relaxation instruction or relaxation techniques alone. All patients received instruction in pain theory. Biofeedback training consisted of 10 50-minute sessions utilizing standard EMG feedback from the frontalis and trapezius muscles and temperature from the third finger of the dominant hand. Visual and auditory feedback was provided. Thirty-three patients were assigned to receive biofeedback plus the relaxation techniques and 31, the relaxation techniques alone. All patients were asked to respond to periodic questionnaires for 36 months. The primary analysis was an intention-to-treat (ITT) analysis. The subsidiary analyses were not and the 11 subjects (7 in the relaxation alone and 4 in the biofeedback group) who received no treatment at all were analyzed and the results were qualitatively the same.
Patients who completed the program with education in pain theory and relaxation techniques showed a statistically significant decrease in the frequency and severity of the headaches in the first 12 months that continued to 36 months. Biofeedback provided no additional benefit, specifically no change in the frequency or severity of the headaches. After 3 months 48% of those in the relaxation group reported fewer severe headaches, while 35% of those in the biofeedback group reported fewer severe headaches; after 6 months, 52% of those in the relaxation group reported fewer severe headaches as compared with 57% reporting fewer severe headaches in the biofeedback group. The number of medications used by the patients and the utilization of medical care decreased in both groups over 36 months suggesting a regression to the mean.
Compliance was an issue throughout the study. Patients dropped out from the outset and that increased over time. Recovery of questionnaires was difficult and fewer were completed at each 3-month interval. Lack of a large control group who did not receive biofeedback or instruction in relaxation techniques.
Biofeedback is an extremely costly and time-consuming treatment modality that, in our study, provided no additional benefit when compared to simple relaxation techniques alone, in the treatment of migraine and tension type headaches in adults.
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